FDA Device · 2012
FDA Device recalls in 2012
RecallRadar indexes 1,310 FDA Device recall notices published in 2012. By classification: 95 Class I, 1,162 Class II, 53 Class III.
- Canon Solid State X-ray Imager (Flat Panel/Digital Imager), Digital Radiography, Models CXDI-55C, CXDI-55G and CXDI-70C. These devices are…
FDA Device · Class II · 2012-09-05 · Canon - PHADIA Varelisa Cardiolipin IgM Cardiolipin autoantibody immunological test system (IgM class antibodies)
FDA Device · Class III · 2012-09-05 · Phadia Us - QKC1692E The QKC1692E Quick Connect device connects endoscopes to the sterilization tray for C1220E liquid chemical sterilization processor
FDA Device · Class II · 2012-09-05 · Steris - Cisco brand HealthPresence, version 2.1
FDA Device · Class II · 2012-09-05 · Cisco Systems - syngo.plaza, Model number 10592457
FDA Device · Class II · 2012-09-05 · Siemens Medical Solutions Usa - TRESTLE LUXE¿ Anterior Cervical Plating System, Product code KWQ. 510(k) K102820
FDA Device · Class II · 2012-09-05 · Alphatec Spine - Whole Body X--ray Scanner This device is indicated as a whole body volume CT system
FDA Device · Class II · 2012-09-05 · Toshiba American Medical Systems - V Series Patient Monitors
FDA Device · Class II · 2012-09-05 · Mindray Ds Usa D B A Mindray North America - Product is labeled in part: "***MEDLINE***Staight Microsurgical Needle 3cm (1.81 ) Length***Reorder: ESE1651***Contents: 1 Each***SINGLE US…
FDA Device · Class II · 2012-09-05 · Unimed Surgical Products - Product is labeled in part: "***MEDLINE***Extended PTFE Coated Blade 6.5 (16.51cm) Length***Reorder: ES0014***Contents: 1 Each***SINGLE US…
FDA Device · Class II · 2012-09-05 · Unimed Surgical Products - The Eon Mini Neurostimulation (IPG) System (Model 3788) is a 16-channel, rechargeable, multi-program system that allows the connection of o…
FDA Device · Class II · 2012-09-05 · Advanced Neuromodulation Systems - Product is labeled in part: "***MEDLINE***Extended PTFE Needle 6.5" (16.51cm) Length***Reorder: ES0016***Contents: 1 Each***SINGLE USE ONLY…
FDA Device · Class II · 2012-09-05 · Unimed Surgical Products - CIDEX OPA, High Level Disinfectant Solution, Glutaraldehyde-free (0.55% ortho-phthaladehyde) solution
FDA Device · Class II · 2012-09-05 · Advanced Sterilization Products - Sunquest Laboratory LabAccess Results Workstation (LARS)
FDA Device · Class II · 2012-09-05 · Sunquest Information Systems - Sunquest Laboratory Versions 6.4 and later using Microbiology Result Entry
FDA Device · Class II · 2012-09-05 · Sunquest Information Systems - ON-Q pump with ONDEMAND bolus button, ON-Q C-bloc with ONDEMAND
FDA Device · Class I · 2012-09-05 · I Flow - Product is labeled in part: "***MEDLINE***Extended PTFE Coated Needle 4.0" (10.16cm) Length***Reorder: ES0016A***Contents: 1 Each***SINGLE…
FDA Device · Class II · 2012-09-05 · Unimed Surgical Products - Product is labeled in part: "***MEDLINE***Extended 5mm PTFE Coated Ball 5.0 (12.70cm) Length***Reorder: ES0009***Contents: 1 Each***SINGLE…
FDA Device · Class II · 2012-09-05 · Unimed Surgical Products - Low Profile Abutment, Non-Hexed Castable Cylinder Model LPCCC1. Product is labeled in part: "***REF LPCCC1***Low profile Abutment Hexed Cas…
FDA Device · Class II · 2012-09-05 · Biomet 3i - DGPHP RFA High-Power Single Use Grounding Pads and Cool-Tip RFA Electrode Kits (containing DGPHP RFA High-Power single use grounding pads)…
FDA Device · Class II · 2012-09-05 · Nellcor Puritan Bennett Dba Covidien - Product is labeled in part: "***MEDLINE***Standard PTFE Coated Blade with Extended Insulation 2.50 (6.40cm) Length***Reorder: ES0012M***Con…
FDA Device · Class II · 2012-09-05 · Unimed Surgical Products - Various SRI Surgical Disposable Accessory Packs
FDA Device · Class II · 2012-09-05 · Sri Surgical - Eon (Model 3716) IPG is a dual channel
FDA Device · Class II · 2012-09-05 · Advanced Neuromodulation Systems - Product is labeled in part: "***MEDLINE***Extended PTFE Coated Needle with Extended Insulation 4.0" (10.16cm) Length***Reorder: ES0016AM***…
FDA Device · Class II · 2012-09-05 · Unimed Surgical Products - syngo Imaging XS. Radiological image processing system
FDA Device · Class II · 2012-09-05 · Siemens Medical Solutions Usa - Philips SureSigns VSi/VS2+ patient monitors Model Part Numbers VSi/ 863275, 863276, 863277, VS2+ 863278, 863279
FDA Device · Class II · 2012-09-05 · Philips Healthcare - Mini-Infuser Model 150XL Single Speed Infusion Pump, an Rx battery operated syringe infusion pump
FDA Device · Class III · 2012-09-05 · Baxter Healthcare - 16 Fr HemoStar XK Long-Term Hemodialysis Catheter, implanted Standard kit containing an AirGuard introducer
FDA Device · Class III · 2012-09-05 · Bard Access Systems - Product is labeled in part: "***MEDLINE***Extended PTFE Coated Blade with Extended Insulation 4.0 (10.16cm) Length***Reorder: ES0014AM***C…
FDA Device · Class II · 2012-09-05 · Unimed Surgical Products - Mini-Infuser Model 300XL Multispeed Infusion Pump, an Rx battery operated syringe infusion pump with an active time scale and rate selector…
FDA Device · Class III · 2012-09-05 · Baxter Healthcare - EXCELART Vantage, Atlas, and Titan MRI Systems, MRT-1503 and MRT-1504
FDA Device · Class II · 2012-09-05 · Toshiba American Medical Systems - Product is labeled in part: "***MEDLINE***Extended PTFE Coated Blade with Extended Insulation 6.5 (16.51cm) Length***Reorder: ES0014M***Con…
FDA Device · Class II · 2012-09-05 · Unimed Surgical Products - UniCel DxI 600 Access Immunoassay Systems, Part Numbers: Dxl 600: A30260
FDA Device · Class II · 2012-08-29 · Beckman Coulter - Conformis iTotal CR-Cruciate Retaining Knee Replacement System Model Numbers: M57250600010 iTotal CR, Left Knee M57250600020 iTotal CR, Rig…
FDA Device · Class II · 2012-08-29 · Conformis - UniCel DxH Slidemaker Stainer Stainer Floor Cabinet, PN A96152
FDA Device · Class II · 2012-08-29 · Beckman Coulter - GEHC OEC Injection Cable for MedRad Provis V Contrast Injector
FDA Device · Class II · 2012-08-29 · Ge Oec Medical Systems - EasyLink Informatic System is included with the Dimension Vista System
FDA Device · Class II · 2012-08-29 · Siemens Healthcare Diagnostics - UniCel DxI 800 Access Immunoassay Systems, Part Numbers: Dxl 800: 937100
FDA Device · Class II · 2012-08-29 · Beckman Coulter - Altrx" Altralinked" Polyethylene liners Description: An acetabular liner is one of the implants used during total hip arthroplasty to repla…
FDA Device · Class II · 2012-08-29 · Depuy Orthopaedics - Interface module for CDl System 100/101 Product Usage: The Interface Module for CDl 500 is the interface between the CDl 500 monitor and th…
FDA Device · Class II · 2012-08-29 · Terumo Cardiovascular Systems - OEC InstaTrak 3500, picture archiving and communications system intended as an aid to locate anatomical structures during open percutaneous…
FDA Device · Class II · 2012-08-29 · Ge Oec Medical Systems - i-STAT cTnI cartridges Product Usage: The i-STAT cTnl test is an in vitro diagnostic test for the quantitative measurement of cardiac tropo…
FDA Device · Class II · 2012-08-29 · Abbott Point - Powered Mobility Offers Versatility (M¿V)TM Chair
FDA Device · Class II · 2012-08-29 · Stryker Medical Division - Powered Mobility Offers Versatility (M¿V)TM Chair The Powered MOV Chair models EMS, EMS24, HHC, and INO Powered MOV Chair, enable two opera…
FDA Device · Class II · 2012-08-29 · Stryker Medical Division - AGFA IMPAC CV DICOMStore with Media Purge Daemon (MPD) and IMPAX CV DICOMStore with Cardiovascular Purge Services (CPS), Medical Image Stor…
FDA Device · Class II · 2012-08-29 · Agfa - UniCel DxH Slidemaker Stainer Instrument System, PN 775222
FDA Device · Class II · 2012-08-29 · Beckman Coulter - Alaris Pump Module Model 8100 (formerly Medley Pump Module) Subsequent Product Code: FPA. The Pump module is intended for facilities that u…
FDA Device · Class I · 2012-08-29 · Carefusion 303 - syngo Dynamics Version 9.5
FDA Device · Class II · 2012-08-29 · Siemens Medical Solutions Usa - OPTETRAK LOGIC Proximal Tibial Spacer & Screws (2) 2.5 LT BLUE Size 2.5, 8mm***STERILE***Match insert/spacer/tray color
FDA Device · Class II · 2012-08-29 · Exactech - Serial interface module RS-485 Product Usage: The System 1 provides perfusion case data transfer through the use of the data transfer module
FDA Device · Class II · 2012-08-29 · Terumo Cardiovascular Systems - The Brilliance 64 and Ingenuity CT are whole body Computed Tomography X-Ray Systems intended to produce cross-sectional images of the body…
FDA Device · Class II · 2012-08-29 · Philips Medical Systems Cleveland - Medtronic O-arm¿ Imaging System
FDA Device · Class II · 2012-08-29 · Medtronic Navigation - Interface module for CDl System 500 Product Usage: The Interface Module for CDl 500 is the interface between the CDl 500 monitor and the sy…
FDA Device · Class II · 2012-08-29 · Terumo Cardiovascular Systems - The Instructions For Use for the following: Stryker TRIO+ 4.5 x 45 mm STANDARD POST SCREW Stryker TRIO+ 4.5 x 50 mm STANDARD POST SCREW Str…
FDA Device · Class II · 2012-08-29 · Stryker Spine - GEHC OEC 8800 Mobile Fluoroscopic X-ray System, GE Healthcare, Surgery, Salt Lake City, UT. Mobile fluoroscopic examination of human anatomy
FDA Device · Class II · 2012-08-29 · Ge Oec Medical Systems - Horizon Medical Imaging system
FDA Device · Class II · 2012-08-29 · Mckesson Medical Imaging Group - Visual-ICE¿ Cryoablation System, Model FPRCH 6000 Product Usage: The Galil Medical Visual-ICE Cryoablation System is intended for cryoabla…
FDA Device · Class II · 2012-08-29 · Galil Medical - Access Total T3 Reagent, PN: 33830 The Access Total T3 assay is used for the quantitative determination of triiodothyronine (T3) levels in…
FDA Device · Class III · 2012-08-29 · Beckman Coulter - GE HC OEC 9900 Elite and GE OEC 9800 Fluoroscopes Snubber Boards are a PCB with a 70 amp fuse to provide fused protection of internal syste…
FDA Device · Class II · 2012-08-29 · Ge Oec Medical Systems - Sunquest Laboratory SMART & Sunquest Laboratory SMART Select Product Usage: for clinical use
FDA Device · Class III · 2012-08-29 · Sunquest Information Systems - Siemens ADVIA Centaur¿ Syphilis (SYPH) Assay , 200 ReadyPack Reference Number 10492493 Product Usage: The ADVIA Centaur Syphilis (SYPH) ass…
FDA Device · Class II · 2012-08-29 · Siemens Healthcare Diagnostics - Oxford Gap Gauge SML 3/4mm
FDA Device · Class II · 2012-08-29 · Biomet U K - Hitachi Echelon MRI System/Oasis MRI, Software
FDA Device · Class II · 2012-08-29 · Hitachi Medical Systems America - The Brilliance 6, 10, 16, 40, 64 and CT Big Bore are Computed Tomography X-Ray Systems These devices may include signal analysis and displa…
FDA Device · Class II · 2012-08-29 · Philips Medical Systems Cleveland - 892.1650 Image-intensified fluoroscopic x-ray system
FDA Device · Class II · 2012-08-29 · Ge Oec Medical Systems - Serial interface module RS-232 Product Usage: The System 1 provides perfusion case data transfer through the use of the data transfer module
FDA Device · Class II · 2012-08-29 · Terumo Cardiovascular Systems - UniCel DxC 660i, 680i, 860i, 880i SYNCHRON Access Clinical Systems, Part Numbers: DxC 660i: A64871
FDA Device · Class II · 2012-08-29 · Beckman Coulter - Sunquest Encompass The reporting site is using the Encompass software in an acute patient care setting
FDA Device · Class III · 2012-08-29 · Sunquest Information Systems - Powered Mobility Offers Versatility (M¿V)TM Chair
FDA Device · Class II · 2012-08-29 · Stryker Medical Division - Powered Mobility Offers Versatility (M¿V)TM Chair The Powered MOV Chair models EMS, EMS24, HHC, and INO Powered MOV Chair, enable two opera…
FDA Device · Class II · 2012-08-29 · Stryker Medical Division - Positron Emission Tomography (PET) and X-ray Computed Tomography, GEMINI TF 16 PET/CT, GEMINI GXL 16 PET/CT, GEMINI TF Big Bore PET/CT, Phi…
FDA Device · Class II · 2012-08-29 · Philips Medical Systems Cleveland - Edwards Lifesciences Swan-Ganz Thermodilution VIP Catheters Model 151F7. For use in patients who require hemodynamic monitoring
FDA Device · Class II · 2012-08-22 · Edwards Lifesciences - Alaris Pump Module model 8100
FDA Device · Class I · 2012-08-22 · Carefusion 303 - BeautyAngel Health Fitness Natural Collagen Stimulation Anti Aging For human use
FDA Device · Class II · 2012-08-22 · Jk Products And Services - The NCB Polyaxial Locking Plate System NCB screws 26mm: 02.03155.026, non-sterile Product is implantable screws indicated for temporary int…
FDA Device · Class II · 2012-08-22 · Zimmer - DePuy Custom Implant Devices Packaging: Packaging was not standardized on customs, it was dependant on the geometry of the product Product…
FDA Device · Class II · 2012-08-22 · Depuy Orthopaedics - Neptune 1 Gold Rover (120 Vand 230V ) Waste Management System Part Number 0700-001-000, 0700-002-000(International) Instructions For Use 07…
FDA Device · Class I · 2012-08-22 · Stryker Instruments Div - System 8000 Base Product Usage: The Sarns Modular Perfusion System 8000 is indicated for use for up to 6 hours on the extracorporeal circu…
FDA Device · Class III · 2012-08-22 · Terumo Cardiovascular Systems - IMPAX Cardiovascular (CV) Reporting Reporting tool used for structured reporting and structured report outputs (including XML style sheet c…
FDA Device · Class II · 2012-08-22 · Agfa - 00-4309-029-00- Trabecular Metal Reverse Shoulder Liner 36mm, Nonsterile Per surgical technique 97-4309-003-00 Revision 4: "Complete Poly L…
FDA Device · Class II · 2012-08-22 · Zimmer - Stryker Neptune Bronze Rover, Part 0700-007-000 Neptune Bronze Rover Waste Management System Instructions For Use
FDA Device · Class I · 2012-08-22 · Stryker Instruments Div - TAUT, Cholangiogram Catheter Intraducer, Peritoneal Catheter, Teleflex Medical, Research Triangle Park, NC. An introduction/drainage cathet…
FDA Device · Class III · 2012-08-22 · Teleflex Medical - Edwards Lifesciences Swan-Ganz Thermodilution VIP Catheters Model 131HF7P. For use in patients who require hemodynamic monitoring
FDA Device · Class II · 2012-08-22 · Edwards Lifesciences - Edwards Lifesciences Swan-Ganz Thermodilution VIP Catheters Model 131HVF7P. For use in patients who require hemodynamic monitoring
FDA Device · Class II · 2012-08-22 · Edwards Lifesciences - Synthes(R) Hemostatic Bone Putty, Part numbers 08.901.001.97S, 08.901.001.98S, 08.901.001.99S, 08.901.001D, and VB1025.10S. Indicated for u…
FDA Device · Class I · 2012-08-22 · Synthes Usa Hq - Maquet Getinge Group Pediatric Arterial Cannula Maquet Cardiopulmonary AG Kehler Strabe 31 76437 Rastatt Germany Phone +49 7222 932-0 Fax:…
FDA Device · Class II · 2012-08-22 · Maquet - GE Healthcare Advantage Workstations, Advantage Worksation version 4.2 and 4.3 with Volume Viewer 2 (version 6.4-6.8) provided with Advance…
FDA Device · Class II · 2012-08-22 · Ge Healthcare - Neptune 1 Silver Rover, Part 0700-003-000 Stryker Instruments Neptune Rover IFU part 0700-001-700
FDA Device · Class I · 2012-08-22 · Stryker Instruments Div - Carestream DRX-1 System Battery --- Made in U.S.A. for Carestream Health, Inc., Carestream Health, Inc., 150 Verona St, Rochester, NY 14608…
FDA Device · Class II · 2012-08-22 · Carestream Health - Edwards Lifesciences Swan-Ganz Thermodilution VIP Catheters Model 141HF7P. For use in patients who require hemodynamic monitoring
FDA Device · Class II · 2012-08-22 · Edwards Lifesciences - 13.5 mm x 60 mm BrainPath Sheath The NICO BrainPath is a family of products that consists of multiple sized reusable and re-sterilizable ob…
FDA Device · Class II · 2012-08-22 · Nico - Edwards Lifesciences Swan-Ganz Thermodilution VIP Catheters Model 141HF7J. For use in patients who require hemodynamic monitoring
FDA Device · Class II · 2012-08-22 · Edwards Lifesciences - Edwards Lifesciences Swan-Ganz Thermodilution VIP Catheters Model 151HF7. For use in patients who require hemodynamic monitoring
FDA Device · Class II · 2012-08-22 · Edwards Lifesciences - Philips Essenta DR, X-Ray System, Diagnostic, general-purpose Model: 712070
FDA Device · Class II · 2012-08-22 · Philips Healthcare - Edwards Lifesciences Swan-Ganz Thermodilution VIP Catheters Model TS057HF7. For use in patients who require hemodynamic monitoring
FDA Device · Class II · 2012-08-22 · Edwards Lifesciences - 00-4309-028-01 - Trabecular Metal Reverse Shoulder Liner 40mm 65¿ Neck Angle Per surgical technique 97-4309-003-00 Revision 4: "Complete Po…
FDA Device · Class II · 2012-08-22 · Zimmer - SenTec, V-Sign"2 Sensors The SenTec Digital Monitoring System (SMDS) is used for continuous and noninvasive real-time monitoring of ventila…
FDA Device · Class II · 2012-08-22 · Sentec Ag - Edwards Lifesciences Swan-Ganz Thermodilution VIP Catheters Model 131HF7J. For use in patients who require hemodynamic monitoring
FDA Device · Class II · 2012-08-22 · Edwards Lifesciences - VITROS Chemistry Products DGXN Slides --- [REF] 834 3386
FDA Device · Class II · 2012-08-22 · Ortho Clinical Diagnostics - Edwards Lifesciences Swan-Ganz Thermodilution VIP Catheters Model 131F7J. For use in patients who require hemodynamic monitoring
FDA Device · Class II · 2012-08-22 · Edwards Lifesciences
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